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Osmunda Medical Device Consulting Organization, the largest and most professional consulting company in the field of medical device in China, provides global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification, medical device clinical trial consulting service etc. We have served over 1000 medical device enterprises in home and abroad, including GE, tyco Electronics, Philips, Sumitomo, Foxconn, SIEMENS and vetch.
Clinical trials must meet the following conditions.
According to the requirement of Regulations for New Drug Approval published by FDA on May 1st, 1999, clinical trial in phase 3 should be accomplished before the application of drug production. Moreover, phase 2 clinical trial should be promptly followed by phase 3.
According to the requirement of Regulations for New Drug Approval, cases of experiment group in phase 3 clinical trial must over 300, but there is no regulation of that of control group.　Cases of control group may depend upon indications of experimental drug and the number of patients. In single indication, 100 cases of experiment group and 100 cases control group(1:1), or 200 cases of experiment group without control group(non-controlled open trial) may be considered. In 2 and above indications, 200 cases of experiment group and 200 cases control group(1:1), or 100 cases of experiment group without control group(non-controlled open trial) may be considered. If permitted, 300 cases of experiment group with the same cases of control group are better. When the trial is conducted to determine whether the experimental drug is significantly superior to the control drug, formula can be applied to calculate the case number.
In theory, requirement of design of control study in phase 3 clinical trials is identical to that of phase 2 blind randomized controlled trial; however, clinical trial in phase 3 can be randomized controlled open labeled clinical trial. Some drugs, such as cardiovascular disease drugs, are performed not only for short-term purpose as observing their effect on blood pressure and blood lipid in certain period of time, but also for long-term purpose as comparing mortality and incidence of serious complications after long-term treatment. In this condition, we can not just increase the cases of phase 2 clinical trials, but to design and plan in detail according to purpose and requirement of the clinical trial. Only by these, can scientific conclusion can be made.
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